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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02662972
Other study ID # BTATN2015
Secondary ID 2015-002643-33
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2016
Est. completion date November 1, 2018

Study information

Verified date July 2019
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered surgery. There are different types of procedures and most of them are complex with a risk for complications. The researchers want to start a pilot study on 10 patients with a new surgical technique using neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an important role in facial pain. There have been a few trials trying to block this structure in trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers technique requires local anesthesia only (awake patient). The researchers believe that this treatment can become a "low threshold"-treatment for patients who do not have enough effect with pharmacological treatment and a better alternative to other complex surgical approaches. Using this new neuronavigation system the researchers can reach this neural structure with high precision.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date November 1, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Informed and written consent

- Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria

- Unsatisfactory effect of pharmacological treatment

Exclusion Criteria:

- Microvascular decompression is seen as a better alternative

- Heart or lung disease

- Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection

- Psychiatric illness that hinders participation in the study

- Known pregnancy or breast feeding

- Inadequate use of contraceptives

- Overuse or abuse of opioids

- Abuse of medications, narcotics or alcohol

- Anomalies which hinder or impede the used method of injection

- Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication

- Treatment with medication that can interact with botulinum toxin type A

Study Design


Intervention

Drug:
Botulinum Toxin Type A


Locations

Country Name City State
Norway Department of Neuroscience, Norwegian University of Science and Technology Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Crespi J, Bratbak D, Dodick DW, Matharu M, Jamtøy KA, Tronvik E. Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia. Headache. 2019 Jul 25. doi: 10.1111/head.13608. [Epub a — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of adverse events Number of adverse events. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations. for the follow-up period of 12 weeks
Secondary Number of attacks with trigeminal neuralgia 12 weeks
Secondary Intensity of the attacks expressed as score on Visual analogue scale (VAS) for pain 12 weeks
Secondary Number of attacks with trigeminal neuralgia per 4 weeks per patient 12 weeks
Secondary Number of doses of analgesics per 4 weeks per patient 12 weeks
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